Implants listed below comply with the CleanImplant Quality Mark Criteria according to the consensus recommendation of the Scientific Advisory Board. This guideline for clean implants was released September 2017 and has yet been established in many implant manufactoring sites as de-facto standard for the cleanliness of implantable devices.

For the comprehensive quality assessment five implant samples of each implant type have been analyzed by means of SEM and elemental analysis. The list of implants (in alphabetic order) with the "Trusted Quality Mark" is continually updated and extended.

The implant system of your choice is not listed below ? Please do not hesitate and send us a mail !

"Trusted Quality" Implant Types 2020 (in alphabetic order)

Bredent Medical – blueSKY

BREDENT_blueSKY_Full-size_high-resolution_image

BREDENT_blueSKY_Implant_thread_500x

Certificate_Bredent_2018-2020[1]

BREDENT_blueSKY_Implant_body_500x

BREDENT_blueSKY_Implant_body_2500x

BREDENT_blueSKY_Implant_body_5000x

Click on the images to enlarge.

BTI – UniCa Implant

BTI_Full-size_high-resolution_image_1

BTI_IIP_Thread_500x_1

Certificate_BTI_2017-2021

BTI_IIP_Implant_body_500x_1

BTI_IIP_Implant_body_2500x

BTI_IIP_Implant_body_5000x_1

Click on the images to enlarge.

Global D – In-Kone

GLOBALD_inkone__Full-size_high-resolution_image

GLOBALD_inkone_SEM-thread_500x_1

Certificate_GlobalD_2019-09-26

GLOBALD_inkone_SEM-body_500x_1

GLOBALD_inkone_SEM-body_5000x

GLOBALD_inkone_SEM-body_2500X_1

Click on the images to enlarge.

Medentis Medical – ICX-Premium

18-00002-128_MEDicxp2401#1_SEM-Mapping_HighRes

Medentis_ICX-Premium_thread_500x

Certificate_Medentis_2019-09-26

Medentis_ICX-Premium_body_500x

Medentis_ICX-Premium_body_2500x

Medentis_ICX-Premium_body_5000x

Click on the images to enlarge.

MegaGen – Anyridge

MegaGen_AnyRidge_Full-size_high-resolution_image

MegaGen_AnyRidge_Implant_thread_500x

Certificate_MegaGen_2017-2021

MegaGen_AnyRidge_Implant_body_500x

MegaGen_AnyRidge_Implant_body_2500x

MegaGen_AnyRidge_Implant_body_5000x

Click on the images to enlarge.

Natural Dental Implants – Replicate

NDI_Replicate_Full-size_high-resolution_image

NDI_Replicate_indent_500x

NDI_Certificate_2017-12-01

NDI_Replicate_Body_5000x

NDI_Replicate_Body_2500x

NDI_Replicate_Body_500x

Click on the images to enlarge.

Nobel - NobelActive

NobelActive_Full-size_high-resolution_image

NobelActive_Thread_500x

Certificate_NobelBiocare_2019-03-05

NobelActive_Body_500x

NobelActive_Body_2500x

NobelActive_Body_5000x

Click on the images to enlarge.

NucleOSS – T6

NucleOSS_T6_Full-size_high-resolution_image

NucleOSS_T6_Thread_500x

NucleOss Cert 17-19

NucleOSS_T6_Implant_body_500x

NucleOSS_T6_Implant_body_2500x

NucleOSS_T6_Implant_body_5000x

Click on the images to enlarge.

Straumann - SLA

Straumann-SLA_Full-size_high-resolution_image

Straumann-SLA_Body_Thread_500x

Straumann Cert. 19-20

Straumann-SLA_Body_500x

Straumann-SLA_Body_2500x

Straumann-SLA_Body_5000x

Click on the images to enlarge.Sweden & Martina - PRAMA

Sweden&Martina_Prama_Full-size_high-resolution_image

Sweden&Martina_Prama_SEM-thread_500x

Certificate_Sweden&Martina_2019-12-20

Sweden&Martina_Prama_SEM-body_500x

Sweden&Martina_Prama_SEM-body_2500x

Sweden&Martina_Prama_SEM-body_5000x

NOTE:

More implants applied for the "CleanImplant Trusted Quality Mark". Analyses of these implants and peer-review processes are pending.

You are missing information about the implant system of your choice?

You don´t have to wait until the results of your specific implant are published in scientific journals. As a Fellow Members of the CleanImplant Community you will receive the desired information for up to three implant systems and a personalized certififcate for your practice. Find out more information about the membership here.

If you want to be sure that your implant system also carries the Trusted Quality Mark, ask the sales representatives or correspondent manufacturer to join the global quality assessment project.

CleanImplant Listed Implants 2019 (in alphabetic order)

Implant systems listed below participated in the Implant Study 2017-2019 conducted by the CleanImplant Foundation or applied separately for a testing report after the study ended. The SEM/EDS analysis of implants in this "Listed" section is based on one single implant sample. Implants are only listed if they technically meet the criteria for "clean implants" as stated in the CleanImplant Consensus Document (guideline released 09.2017). Testing is performed and results are confirmed by an officially accredited testing institute according to DIN EN ISO/IEC 17025.

Note: Clinical documentation is no precondition for this Listing and was not checked. All images are copyright protected.

Camlog Biotechnologies | Screwline

DIN EN ISO/IEC 17025 report: 18-000002-001

Testing report issued: 2018-03-18

Tested implant production date: 2017-12

Tested implant validation date: 2022-12

Website of manufacturer: www.camlog.com

Notes/Comments: Sample showed no significant contamination within the scope of the analysis. The implant sample showed a clean surface with only isolated organic particles (<10) and few remnants of the blasting material aluminum oxide (10 μm). Implant is "clean" according to the CleanImplant Consensus (release date 09.2017)

Novodent | i-System

DIN EN ISO/IEC 17025 report: 18-000002-097

Testing report issued: 2019-05-10

Tested implant production date: 2018-11

Tested implant validation date: 2023-11

Website of manufacturer: www.isystemimplant.com

Notes / Comments: Sample showed no significant contamination within the scope of the analysis. The implant sample showed a clean surface with only isolated particles of aluminum oxide (10-30 μm) as remnants from the blasting process. Implant is "clean" according to the CleanImplant Consensus (release date 09.2017)

SEM results and images of the Implant Study 2017-2019

We analyzed already numerous implant types from manufacturers of more than 20 countries and recent production following our accredited and thorough protocol of analysis according to DIN EN ISO/IEC 17025. Results will be published in scientific peer-reviewed journals in 2019. Fellow Members of the CleanImplant Community can apply for preliminary results of analysis about implants they have in use. Find out more here

SEM results and images of the Implant Study 2014-2015

Until recently we showed here data and numerous images from a previous study with SEM/EDS results of older implants (Production Date 2012-2015). Unfortunately some manufacturers misused this information for commercial purposes and connected these older data to their implants of recent production - in some cases ignoring contaminations on implants of new production. Thus, we decided to take the complete data off the net.

The full report based on the Implant Study 2014-2015 (released April 2016) with 822 pages and 2.950 SEM images of 135 different implants (95 brands) including 150 qualitative and quantitative elemental analyses can be ordered for a fee (PDF or printed version).

Become a member !

Find more information here

Important note:

Below you can find different examples of inorganic and organic implant pollution.

We do not intend to publish the name of the implant manufacturer(s) or type of these analyzed implants for three reasons:

First of all some implant companies already tried to threaten us with steps of legal action after we informed them about the scientific results of single sample SEM / EDX analysis.

Second we prefer to concentrate our energy and resources into building a stage for companies who care for their quality and for products that deserve our trust.

And last but not least it is not our intention to stigmatize specific manufacturers as there is always a chance for improvement in the manufacturing of dental implants.

Examples of Implant Residues

Single organic particles (1-5 particles) were found on many implants. Clinical effects of these isolated particles can be considered as negligible.

However, a significant number of implants showed a systematic distribution pattern of organic particles i.e. mainly on the outer threads of the implant or on the shoulder area. In the material contrast SEM images these particles appear dark in comparison to titanium or zirconium (see below).

Two samples showed traces of carbon and fluorine in the elemental spot analysis of fibres (5-50 µm). These fibres are probably remnants of polytetrafluoroethylene (PTFE) originating from teflon coated baskets used during the production process.

Significant signals ofiron <Fe>, chromium <Cr> and nickel <Ni> in the elemental spot analysis of particles (20-50 µm) on this implant may be a hint for recycled or polluted blasting material containing particles of stainless steel (see below).

Some particles (1-5 µm) showed clear fingerprints of copper < Cu > and tin < Sn> in the elemental analysis as seen in the images below. These metal particles appear bright in the material contrast SEM image and are each embedded in larger organic contaminants (30-100 µm).

Surprisingly traces of antimony and tungsten were found in the EDX analysis of sterile packed implants.

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